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NCT03119935 Clinical Trial

Amflow-device Can Help Proper Ambu-bag Ventilation

Ventilation Therapy; Complications Clinical Trial

Official title:
Evaluation of an Amflow-device Assist Ambu-bagging to Improve Accuracy of Tidal Volumes Delivered.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03119935
Other study ID # Amflow
Secondary ID
Status Completed
Phase N/A
First received April 14, 2017
Last updated December 17, 2017
Start date March 1, 2017
Est. completion date September 1, 2017

Study information
Verified date December 2017
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a simulation study with a prospective randomized cross-over design. The aim of this study is to evaluate whether Amflow-assisted ambu-bag can delivery the accurate tidal volume compare to ordinary ambu-bag

Description:

Ambu-bag ventilation is an essential skill to the patients who needed ventilatory support. However, the delivery of appropriate amount of tidal volume by ordinary manual bag ventilation may be difficult. In addition, it require adequate training to rescurer.

We hypothesised that an Amflow assist ambu bag may be helpful to delivery accurate tidal volumes to the patients.

Participants performed bag-valve ventilation to manikin by ordinary technique and Amflow assist technique in our simulation centre. We measured each ventilation rate and ventilation volume in simulated scenario and we compare those between two technique.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date September 1, 2017
Est. primary completion date August 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- A healthy senior medical students who agree attend this study.

Exclusion Criteria:

- A participants who does not agree attend this study

Study Design

Related Conditions & MeSH terms

  • Ventilation Therapy; Complications

Intervention

Device:
• Amflow
Amflow deviced was developed for monitoring ventiation rate and ventilation volume. Participants ventilated the simulated patients by Amflow-device assist ambu bag
• Ambu bag
Participants ventilated the simulated patients by ambu bag

Locations
Country Name City State
Korea, Republic of Department of Emergency Medicine, Konkuk University Medical center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tidal volume We compared mean tidal volume delivered to manikins between two techniques 6 minutes
Secondary Ventilation Rate We compared mean ventilation rate between two techniques 6 minutes
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